BioOutsource is the industry leader in the biological analysis of monoclonal antibodies. We have developed a range of off-the-shelf Lucentis (ranibizumab) assays to support Lucentis biosimilar manufacture, process development, characterisation and similarity studies which can be adapted for your Lucentis material if required. We have extensive experience in the development, optimisation and qualification/validation of custom cell based bioassays to assess the myriad of functions that can be mediated by monoclonal antibodies, and their derivatives.
The bioassay is the only analytical method that directly measures the biological activity of Lucentis and therefore represents one of the most important assessments that should be conducted as part of product characterisation, lot release and stability programs. The ICH guideline Q6B – Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products describes the bioassay as:
Assessment of the biological properties constitutes an equally essential step in establishing a complete characterization profile. An important property is the biological activity that describes the specific ability or capacity of a product to achieve a defined biological effect.
BioOutsource currently offers the following Lucentis bioassay:
If you require a Lucentis bioassay method that is not listed, please contact us.